MULTI-MOTION MULTIPLE BIOPSY SAMPLING DEVICE

Abstract: This invention is an instrument for obtaining tissue samples comprising a device body (16) having sampling storage space (27), and a cutting member (20, 21) to take multiple samples and store them in the storage space (27).

Description: MULTI-MOTION MULTIPLE BIOPSY SAMPLING DEVICE Field of the Invention This invention relates to taking samples of tissue from the body. Background of the Invention Tissue samples can be examined in a laboratory to determine the presence of a pathological disorder (e.g. malignancy) . Often, the samples must be obtained from deep within the body using a medical sampling instrument. It is usually best to obtain several samples around the location where the disorder is suspected so that the presence and progress of disease, if any, can be accurately determined. The samples must be catalogued according to the location from which each sample is taken and the integrity of the samples must be maintained for the subsequent laboratory analysis. Summary of the Invention In an aspect, the invention features an instrument for obtaining tissue samples from a site deep within the body. The instrument has an elongated proximal portion that is constructed to follow a long, torturous path to the site and a distal end constructed to remove a tissue sample from the body, including tissue specimens, polyps or the like. The instrument is constructed to take multiple biopsy samples without being withdrawn from the body by including a device body defining a storage space along the axis of the device suitable for storage of multiple, successively taken samples. The instrument includes a sampling assembly having a cutting member, constructed such that it can be actuated in a first, rotary motion to take a tissue sample from the body and a second, axial motion for disposing the sample axially into the storage space. Embodiments may include one or more of the following features. The cutting member is a jaw-like member, the first motion is a radial jaw opening and closing motion, and the second motion is an axial motion wherein the sample is pulled by the jaw-like member into the storage space. The instrument includes a second jaw¬ like cutting member that is constructed for radial motion and is axially stationary. The first jaw-like cutting member is constructed such that it can be actuated to move transversely into space defined by the second jaw¬ like member to engage a sample cut by the members prior to the axial motion. The cutting member is attached to a tubular member defining the storage space. The tubular member and cutting member include a slot and pin camming arrangement constructed to allow the motions by relative axial movement of the tubular member and the cutting member. The slot is provided on the cutting member and the pin is provided on the tubular member. The camming arrangement provides, in order, opening motion of the cutting member, closing motion of the cutting member, transverse motion of the cutting member to facilitate engagement with a sample cut by the member, axial motion for disposing the sample in the storage space, and axial motion for returning the cutting member to a position in preparation for taking another sample. The instrument includes a second jaw like member that is constructed for radial and axial motion. The first and second jaws are coupled to the instrument at a distal end portion that is rigid relative to a flexible portion proximal thereof. The rigid distal end portion has an axial length that is about equal to or shorter than the axial length of the jaws. The rigid distal end portion defines a space that has an axial length that is about equal to the axial length of the jaws and the jaws are moveable proximally within the distal end portion. The distal end portion has a length of about 5-7mm. In another aspect, the instrument includes a side- facing sampling element constructed such that it can be actuated in a first, rotational motion about the device axis to separate a tissue sample from the body and a second, axial motion for disposing the sample axially to facilitate positioning the sample in the storage space. Embodiments of this aspect may include one or more of the following features. The sampling element has an integral, axially adjacent sample-engaging surface for engaging a sample during axial motion of the element. The sampling element is a tube-form including a side- facing cutout defining a cutting surface and the sample engaging surface, and the storage space is defined by a portion of the tube-form adjacent the cutout. The storage space is proximal of the cutting element. The instrument includes a retention formation constructed such that the sample can be moved in a first axial direction by the sampling element into contact with the retention formation. The sampling element can be moved in the second axial direction while the sample is retained axially stationary by the retention formation. The retention formation is a high friction surface. The sampling element is constructed to prevent abrasion of the sample against the retention formation as the sample is moved axially in the first axial direction. The instrument includes an outer sleeve wherein the sampling element is moveable relative to the outer sleeve, and the retention formation is provided on the outer sleeve. The retention formation is provided on a small portion of the interior surface of the outer sleeve that is about equal to or less than the circumferential width and £<ial length of the side-facing cutout of the sampling element. The sampling element includes a scraping surface constructed to move between a tissue sample and a retention formation to facilitate transfer of the sample into the storage space as the sample element in the second axial direction. The retention formation is formed by sandblasting. The sleeve includes a side- facing opening through which tissue may pass to be engaged by the cutting surface of the sampling member. The interior sample contacting surfaces of the storage space include a low friction coating that allows easy axial relative displacement of the surfaces and the sample. The low friction coating is provided by a hydrogel coating. The instrument includes an axially moveable sample-retaining element constructed to engage and maintain samples in the storage space as the sampling element moves axially into a cutting position. Other features and advantages and methods of use follow. Brief Description of the Drawing We first briefly describe the drawings. Fig. 1 is a perspective view of an embodiment of the invention being delivered into the body through an endoscope; Fig. 2 is a cross-sectional view of an embodiment with the jaws open, Fig. 2a is an end-on cross-sectional view of the embodiment with the jaws open, and Fig. 2b is a perspective view of one of the jaws; Fig. 3 is a cross-sectional view of an embodiment of the invention with the jaws closed; Fig. 4 is a cross-sectional side view with one of the jaws retracted; Figs. 5-5e illustrate a use of another embodiment; Fig. 6 is a side view of another embodiment with the jaws open, while Fig. 6a is a similar view with the jaws closed, and Fig. 6b is a similar view with the jaws retracted; Figs. 7-7e are views of components of the embodiment of Fig. 6, including a side view of a coupling section (Fig. 7) , a perspective view of the coupling section (Fig. 7a) , a side view of a jaw (Fig. 7b) , a top view of a jaw (Fig. 7c) , a perspective view of a jaw (Fig. 7d) , and a top view showing a stamped cut piece of metal that can be subsequently formed into a jaw (Fig. 7e) . Fig. 8 is a cross-sectional view of an embodiment of the invention; Fig. 8a is a top view of the embodiment; Fig. 8b is a greatly enlarged view of the area in circle b in Fig. 8; and Fig. 8c is an end on cross section taken along the lines cc in Fig. 8; Figs. 9-9e illustrate a use of the embodiment of Fig. 8; Fig. 10 is a cross-sectional view of an additional embodiment of the invention; Fig. 10a is a top view of the additional embodiment; Figs. 11-llf illustrate a use of the additional embodiment; Fig. 12 is a cross-sectional view of an additional embodiment; Fig. 12a is a cross-sectional view of an additional embodiment; Fig. 13 is a cross-sectional view of another embodiment; Fig. 14 is a cross-sectional view of another embodiment. Description of the Preferred Embodiments Referring to Fig. 1, the device 10 for multiple biopsy sampling may be delivered into the body through the channel of an endoscope device 11 (e.g., gastroscope, sigmoidoscope, or colonoscope) . The endoscope device typically has a length of about 100-250 cm and a channel diameter of 2.0 - 3.8 mm, typically about 2.8 mm. A distal sampling portion 16 is extended from the endoscope for cutting and storing a sample of tissue from a body surface 18 of a patient (e.g. from a surface in the gastrointestinal tract or bronchial tract) . The device has a diameter of preferably around 1.8 - 2.4 mm, typically about 2.3 mm or less and is of sufficient flexibility so it passes easily though the channel when the endoscope follows a tortuous body passageway. The endoscope may include other lumens for water, air, suction, and viewing, for example. Devices according to the invention can be adapted to be introduced to sites (e.g., urinary tract, reproductive organs, cardiac tissue, or the like) deep within the body by other means. For example, a device can be configured with a lumen so that it can be advanced over a guidewire, e.g., in vascular applications. The device may be passed through an introducer or guiding catheter in, e.g., cardiac applications. The sampling and storage arrangements may be useful in open surgery applications. Referring particularly to Figs. 2-4, the sampling portion 16 includes jaws 20, 21, coupling section 25, control wires 22, 23, and sleeve 24. All or part of surfaces 18 and 19, on jaws 20, 21, may be sharpened or serrated to facilitate cutting. Each jaw 20 and 21 also has ear-forms 29. Control wires (or rods) 22, 23 are connected to the proximal end of ear-forms 29 and are used to radially open and close jaws 20 and 21 by manipulating the control wires 22, 23 from outside the body, as will be discussed further below. On jaw 20, ear-form 29 has a bore 30 and on jaw 21 ear-form 29 has a cam slot 28. Jaws 20 and 21 are attached to sleeve 24 by rigid coupling section 25 using pivot pins 26. Pivot pins 26 are cantilevered from coupling section 25 and extend through cam slot 28 and bore 30. Sleeve 24 has storage space 27 to store at least, preferably five or more, samples. Ear-forms 29 are constructed so they act in cooperation with pivot pins 26 such that axial force by the control wires 22, 23 is cammed to radial motion of jaws 20, 21. Cam slot 28 in jaw 21 has a width of about 0.003 inch and is formed in the side flattened portion 31 of jaw 21. Side flattened portion 31 is about 0.005- 0.006 inch wide (Fig.2b) . The axial length of jaw 21 is about 5-7 mm. Jaw 21 is slightly shorter and narrower than jaw 20 so that jaw 21 can fit at least partially inside jaw 20, as will be discussed below. The circumferential shape of the jaws 20, 21 must be complementary to the shape of the coupling section 25 and storage space 27 so that travel along the cam slot 28 does not cause transverse motion of the jaws 20, 21. Referring particularly to Fig. 2, with control wires 22, 23 pushed distally, the jaws are forced into an open position by radial rotation about the pivot axis defined by the pins 26 (arrows 32, 33) . Referring particularly to Fig. 3, with control wires 22, 23 pulled proximally, the jaws are forced into a closed position (arrows 34, 35). Referring particularly to Fig. 4, with control wire 23 pulled further proximally, the jaw 21, following a path defined by the cam slot 28, first moves transversely into the space defined by jaw 20, to grasp or capture the sample that has been cut (not shown) , and then proximally, to draw the sample into storage space 27 (arrows 36, 37). The proximal portion of jaw 21 includes a cutaway 38 (see Fig. 2a) so that jaw 21 does not bind on a sample which has been placed in storage space 27 as jaw 21 moves distally from the storage space to prepare to cut another sample. The pivot pins 26 are cantilevered from coupling section 25 so as not to extend across the diameter of the device thus providing a relatively large storage space 27 for storing samples. Previous samples can be stored in storage space 27 while succeeding samples are taken, thus allowing multiple samples to be taken without removing the device from the endoscope. Sleeve 24 may include lumens (not shown) for control wires 22, 23 to separate the control wires 22, 23 from samples stored inside the storage space 27 and enable the control wires 22, 23 to move freely. In alternative embodiments, the sample storage space may include a barbed spear-form member (not shown) , e.g., a stationary or axially moveable barbed spear-form, to pierce the samples and hold them in place. The axially moveable jaw 21 may include a member extending from the control portion 29, radially across the space 27. This member bears on previously taken samples to help urge them proximally as a succeeding sample is being drawn proximally into the space by jaw 21. The member can be made flexible or adjustable so that it does not push the last taken sample distally as the jaw 21 moves distally to prepare to take an additional sample. Further, a separate, axially moveable rake-type member could be provided to bear on previously taken samples to help urge them proximally as a succeeding sample is being drawn proximally into the space by jaw 21. An advantage of this embodiment is that the distal end of the device is rigid for only a relatively short axial length, which makes it easier to thread the device through tortuous passageways with sharp curves. In the preferred embodiment, only the jaws 20, 21 and the short coupling section 25 (total length, typically 5-14 mm) are relatively rigid. These components are formed of metal or a stiff polymer such as Ultem (polyetheramide, General Electric) that can withstand the forces applied during jaw actuation. The proximal portion, such as the sleeve 24, is highly flexible. It is formed . a flexible polymer and/or surrounded by a flexible coil. The storage portion therefore, may also be flexible for most of its length. The device can be configured to take and store many samples, e.g., greater than fifteen, from a highly tortuous body passage way due to the short, stiff distal portion and long, flexible sleeve 24. In embodiments, both of the jaws can be made axially moveable. In this case, the stiff coupling section 25 may be of comparable length to jaws 20, 21 so the jaws 20, 21 can be placed inside the coupling section 25 during entry into and removal from the body. Referring to Figs. 5a-5e, particularly Fig. 5, in use, jaws 20, 21 of the device are first brought close to a tissue surface 18 where a sample is to be taken. (In tnis illustration, the cam slot 28 is positioned near the top of the jaw 21 to maximize the transverse motion) . Referring to Fig. 5a, control wires 22, 23 are pushed distally to force open jaw members 20, 21 by acting against the pivot pins 26. With jaws 20, 21 open, the device is advanced so the jaws come in contact with tissue surface 18. Referring to Fig. 5b, the control wires are pulled proximally to close jaws 20, 21 and to separate a first sample 40 from tissue surface 18. Referring to Figs. 5c and 5d, the first sample 40 is brought into sample storage space 27 by pulling on control wire 22, moving jaw 21 proximally with respect to jaw 20. Referring particularly to Fig. 5c, cam slot 28 is arranged so that jaw 21 moves transversely into jaw 20 to trap the sample 40. Referring particularly to Fig. 5d, continued proximal movement of control wire 22 moves jaw 21 axially to place the sample 40 in sample storage space 27. Control wire 22 is then pushed distally to return jaw 21 to a position opposing jaw 20. Referring to Fig. 5e, subsequent samples 42-46 can be taken without removing the device from the endoscope by repeating the above sequence. The samples 42-46 are brought into the sample storage space 27 in the order in which they were collected. After sufficient samples have been taken, the device is removed from the endoscope and the samples recovered, e.g. by using a pusher (not shown) inside the sample space 27 to push the samples out through the open jaws. Referring to Fig. 6-7a in another embodiment the sampling portion 48 includes jaws 50 that can be radially opened (Fig. 6) and closed (Fig. 6a) , to take a sample, and then drawn axially proximally, to pull the sample into a storage space 56 (Fig. 6b) . (When jaws 50 are in the closed position, surfaces 52 are in contact with one another. The drawings show otherwise for clarity) . All or part of surface 52 of jaws 50 may be sharpened or serrated to facilitate cutting. The embodiment includes a relatively flexible proximal sleeve 54 defining most of the storage space 56 and a relatively stiff coupling section 58. The coupling section 58 includes two sets of cam slots for defining the motion of each of the jaws. Each of the sets includes a cam track 60 on the sides of the coupling section 58 and cam slot 62 that is near the top and bottom of the coupling section 58. The cam track 60 defines a track for pins 64 that are attached to ear- forms 66 extending proximally from the jaws (jaws and ear-forms integrally formed of 0.004 inch stainless steel) . The cam slots 62 couple to jaw slots 68 so the top portion 51 of jaws 50 can ride on the outside of the coupling section 58 as the jaws 50 are drawn proximally into the storage space 56. (To assemble the device, the jaw slots 68 are closed (e.g. by welding) at the back portion 55 after the jaws have been aligned and positioned on the device.) The jaws 50 are controlled by control wires 70 (0.004 inch steel cable) that are attached to the interior extensions 72 of the pins 64 (Fig. 7c) and can be extended or withdrawn from outside the body. The coupling section 58 is relatively rigid, e.g. a metal (0.004 inch thick stainless steel), and the sleeve 54 is relatively flexible, e.g. a polymer. The axial length of the coupling section is approximately the same as the jaws 50, e.g. 5-7mm. In use, the device is inserted into the body, e.g. through an endoscope, with the jaws retracted into the coupling section 58 (Fig. 6b) . The relatively stiff coupling section 58 provides protection for the jaws 50 during delivery into and removal from the body (and thus allows the jaws to be made thinner, cheaper, and more flexible) . Moreover, retracting the jaws 50 makes delivery through tortuous passageways easier since the length of the stiff portions of the device is reduced compared to the jaw extended configuration. Once the sampling site is reached, the jaws 50 can be extended out of the coupling section 58 by extending the control wires 70 which causes the pins 64 on the jaw ears-forms 66 to follow the cam track 60 to a point where the track bends (Fig. 6a) . At the same time, the top portion 51 of the jaw 50 travels over the top 53 of the coupling section 58 as allowed by the cam slots 62 on the coupling section and jaw slots 68 on the top of the jaws 50. The jaws 50 are opened by continuing to extend the control wires 70, which causes the pins 64 to follow the cam track 60 in a transverse direction. The top of the jaws, having reached the proximal end of jaw slot 68 and the distal end of cam slot 62, pivot about the location where the proximal end of the jaw slot 68 engages the distal end of slot 62 (Fig. 6) . The open jaws 50 are pushed forward against the tissue surface 80 where a sample is to be taken (not shown) . The jaws 50 are then closed by withdrawing the control wires 70, causing the pins 64 to travel transversely and the jaws 50 to pivot closed about the distal end of the slot 62. With the jaws 50 closed, the sample, now cut and captured between the jaws 50 (not shown) , can be pulled proximally by further withdrawing the control wires 70 so the pins 64 follow the axial portion of the cam track 60 and the top portion 51 of the jaws 50 slides over the top portion 53 of the coupling section 58. The sequence above can be repeated to take additional samples without removing the device from the body. Each successive sample is drawn back by the jaws 50, pushing the previous samples proximally into the storage space 56 within sleeve 54. When a sufficient number of samples have been taken, the jaws 50 are retracted into the coupling section 58 to protect them and reduce the axial stiffness, and the device is removed from the body. The samples can be retrieved by opening the jaws and providing gentle suction to draw them from the distal end. Alternatively, a pusher, which can be extended distally from the proximal end of the storage space can be used to push the samples out of the open jaws. As shown in Fig. 7e, the jaw 50 may be made from flat stock that is stamped, cut out, and then formed into the three dimensional jaw by welding, for example. In embodiments, optionally, the device can be provided with alternate means to facilitate drawing samples into the storage space, such as an axially moveable barbed spear-form that can be extended to pierce the samples and then drawn proximally. A tongue or rake- shaped member can also be provided for this purpose. The jaws can also be moved separately. For example, one jaw can be moved relative to the other jaw to create a shearing action that helps cut tissue from a surface after it has been grasped by the jaws. This reduces the amount of force needed in radial motion to perform the cutting function and thus allows thinner, more flexible jaw construction. Preferably, the jaws are provided with serrated cutting edges when used in this way. Still other embodiments are within the following claims. For example, the radial and axial motion of the jaw could be provided by multiple control wires attached directly to the jaw. One wire could be connected to the distal end of the jaw to control radial motion and another wire connected to the proximal portion of the jaw to control axial motion. The jaw is provided with a straight slot so it can be slid axially into the storage space without transverse motion. These wires may be positioned to extend outside of the tube defining the sample space. Referring to Figs. 8-8c, in another embodiment the sampling portion 116 includes an outer sleeve 124 concentrically positioned about an inner, generally tubular member 120. The sleeve 124 includes a side- facing opening 129 at its distal portion and a generally tubular body at its proximal portion. The inner tubular member 120 has a side-facing cutting member at its distal portion and a generally tubular proximal portion defining a sample storage space 126. The cutting member includes a side-facing opening 131 defined at its periphery by sharp cutting edges 122 and a distal end 123 that extends partially across the radius of the member 120. The member 120 is actuatable in two motions. It can be rotated about the device axis A to cut a sample from a tissue surface. It can also be moved axially to pull the cut sample into the storage space 12£ where previous samples can be stored while subseguc samples are being taken, thus allowing multiple samples to be taken without removing the device from the endoscope. Referring particularly to Fig. 8b, the interior walls of member 120 are provided with a low friction surface, for example, by providing a coating 132. Referring as well to Fig. 8c, the sleeve 124 includes a roughened high friction segment 133 along its inner surface at a location adjacent the opening 129. The high friction segment 133 is provided at only a small axial and circumferential portion of the interior wall of the sleeve 124 so it does not interfere with the motions of the member 120. The remaining portions of the inner wall of the member 124 may include a low friction coating to facilitate sample movement and the motions of member 120. As will be discussed further below, the high friction segment 133 on the sleeve, in cooperation with the low friction coating 132 on the interior of the member 120, permits cut samples to be urged into the sample storage space 126 as the member 120 is advanced distally to prepare it for taking further samples. Moreover, the location of the segment and the construction and rotational actuation of the member 120 prevents the sample from being abraded by the segment 133 as it is drawn axially proximally. The member 120 is also provided with a scraping element 141 that extends radially somewhat so that it lightly contacts the interior surface of the sleeve to help guide the sample into the storage space. The device also includes an axially moveable discharge pusher 125 for removing the samples from the storage space. A flexible coil 127 is attached to the proximal portion of the sleeve 124. The coil may be provided within a slippery, flexible polymer sleeve (not shown) as known in the art. The rotational and axial motions of the member 120 can be controlled from the proximal portions of the device outside the body by a torqueable control wire (not shown) that is attached to the distal portions of the member 120 and extends proximally. Referring to Figs. 9-9e, particularly to Fig. 9, in use, the device is positioned adjacent a tissue area, such as a polyp feature 119 which is to be sampled. The device may be urged against the tissue surface so that the feature 119 passes through the openings 129, 131 of the sleeve 124 and the member 120. Referring particularly to Fig. 9a, the member 120 is rotated 180° about axis A causing a shearing action of cutting surface 122 upon the tissue surface 118 (arrow 137) . The first sample, sample 140, is thus separated from the tissue surface and captured between the cutting portion of the member 120 and the interior walls of the sleeve 124. Referring to Fig. 9b, the member 120 is then moved axially proximally, causing the radially extending end 123 of the member to engage the distal portion of the cut sample 140 and move the sample proximally. During axial motion, the sample is not rubbed against the high friction segment 133 of the sleeve. Instead, with the member 120 oriented as shown, the outer surface of the member 120 is exposed to the high friction segment and the sample 140 engages only the relatively low friction portions of the interior surface of the sleeve. This is an advantage since the sample is not abraded as it moves distally; abrading the sample could damage it and make later biopsy analysis more difficult. The sample is withdrawn proximally until it reaches an axial location that is in alignment with the high friction surface 133. Referring to Fig. 9c, the member 120 is again rotated 180° about its axis. Because of the low friction surfaces on the inner walls of member 120, the member rotates about the sample, which remains substantially axially stationary, although it moves radially somewhat as the member 120 slips around it. By this rotation, the sample 140, extending through the opening 129, is placed in contact with the high friction segment 133 of the sleeve 124. Referring to Fig. 9d, the member 120 is then extended distally to prepare the device for taking another sample. The sample 140 does not travel axially with the member 120 but is instead restrained from axial motion by the segment 133. Moreover, as the member moves axially, the sample slips into storage area 126 of member 120 since it slides easily on the high friction surfaces on the walls of member 120. The scraper 141, which is angled slightly so it engages the segment 133, acts like a spatula to help slip the sample into the storage area as the member 120 moves distally. Referring to Fig. 9e, subsequent samples 142 can be taken without removing the device from the endoscope by repeating the above sequence. Samples are brought into the sample storage space 126 in the order in which they were collected. To remove the samples from the device, the push rod 125 is moved axially distally and each sample is removed through the openings 129 and 131, for example, using forceps. The member 120 and sleeve 124 can be formed of biocompatible materials such as stainless steel, aluminum, or plastics. The length of the member and the sleeve are relatively short, e.g., on the order of about 1 inch, so the device can be passed through tortuous passageways without being hung up because of the stiffness of the end 116. The device is preferably dimensioned to take and store at least five samples before removing it from the body. The high friction segment 133 may be formed, for example, by sandblasting or etching, or it may be formed by depositing a high friction adhesive coating on the inner wall of the si--;eve. The low friction surface on the interior walls of the member 120 may be provided by depositing a coating of a polymer such as teflon or, more preferably, a hydrogel. A suitable hydrogel is discussed in Fan U.S. 5,091,205. For embodiments constructed for use in vascular applications, the hydrogel coating can be made antithrombogenic, as discussed in Sahatjian U.S. 5,135,516. A low friction coating may also be provided on the outer surfaces of the member 120 and the inner surfaces of the sleeve 124 (except for the segment 133) to reduce frictional resistance to the motions of the member 120. The low friction coating is low compared to the high friction segment 133 of the sleeve 124. In embodiments, the interior walls of the member 120 may have sufficiently low friction without a coating or further treatment. The scraper 141 may also have a high friction inner and/or outer surface. The scraper 141 preferably is a thin extension from the member 120 that has some elasticity that allows it to engage the high friction segment of the sleeve without binding as the member is moved distally. The scraper may be omitted in embodiments where there is sufficiently small clearance, e.g., on the order of 0.001 inch, between the sleeve 124 and the member 120. The proximal portion of the control wire outside the body may include index markings that indicate the axial location of the member 120 relative to the sleeve 124. Referring to Figs. 10-lOa and 11-lle, in another embodiment, the sampling portion 116 includes an axially moveable sample indexer 150 with a sample engaging head 152. In this embodiment, the high friction segment of the sleeve 124 may be omitted. Samples move proximally when engaged by the head but because the indexer 150 is narrow and may include a low friction coating samples do not move distally when the head is advanced (Fig. 10a) . Referring to Figs. 11-llf, particularly Fig. 11, in use, cutting surface 122 is first brought close to tissue surface 118 where a sample is to be taken. The sample indexer is extended axially such that the head 152 does not substantially obstruct the opening 129. Referring particularly to Fig. 11a, member 120 is rotated about axis A causing a shearing action of cutting surface 122 upon tissue surface 118. The sample is separated from the tissue and first sample 140 is collected. Referring to Fig. lib, both member 120 and sample indexer 150 are pulled axially proximally. The head 152 and the distal end 123 of the member 120 engage the sample and pull it axially proximally. Referring to Fig. lie, the member 120 is then again rotated about axis A. Referring to Fig. lid, the member 120 is then pushed axially distally to prepare to take another sample. While the member 120 is being pushed axially distally, sample indexer 150 remains in its proximal position to retain sample 140 in sample storage space 126. Referring to Fig. lie, the sample indexer is then advanced axially distally to its original position. Subsequent samples can then be taken. Referring to Fig. llf, subsequent samples 142 and 144 can be taken without removing the device from the endoscope by repeating the above sequence. The samples are brought into the sample storage space in the order in which they were collected. To remove samples from the device, push rod 125 is moved axially distally and each sample is removed through access hole 128, for example, using forceps. Referring to Fig. 12, in other embodiments, member 120 and sleeve 124 are modified by placing a hole through their distal ends so that sample indexer 150 can thus be advanced to push the head 152 distally through the end 123 of the member 120 and sleeve 124 allowing more room for sample capturing and for sample access during sample removal. Referring to Fig. 12a, in embodiments, sample indexer 150 also carries a sample discharge surface 154 that can be used to remove samples from the storage space by extending the indexer distally. Referring to Fig. 13, in embodiments, member 120 has index points 160 in the storage space. The index points 160 are flexible radial extensions from the inner wall of the member 120 that are angled to be easily bent when samples are urged proximally but inhibit the samples from moving distally. The index points 160 can be bent (elastically in a multi-use device) distally to remove the samples from the storage space when greater force is applied by the discharge pusher 125. Referring to Fig. 14, in still further embodiments, proximal portions of member 120 are removed to reduce the frictional contact with the inner surface of the sleeve 124. The sample space 126 is defined by the remaining arc-form of the member 120 and the proximal portions of the sleeve 124. Still other embodiments are within the following claims. For example, a barbed spear-form can also be used to hold samples in the storage area. What is claimed is:

Claims: 1. An instrument for obtaining tissue samples from a site deep within the body, the instrument having an elongated proximal portion that is constructed to follow a long, torturous path to said site, and having a distal end constructed to remove a tissue sample from the body, including tissue specimens, polyps or the like, wherein said instrument is constructed to take multiple biopsy samples without being withdrawn from the body by including a device body defining a storage space along the axis of said device suitable for storage of multiple, successively taken samples, and said instrument includes a sampling assembly having a cutting member, constructed such that it can be actuated in a first, rotational motion to take a tissue sample from the body and a second, axial motion for disposing said sample axially into said storage space. 2. The instrument of claim 1 wherein said cutting member is a jaw-like member, said first motion is a radial jaw opening and closing motion, and said second motion is an axial motion wherein said sample is pulled by said jaw-like member into said storage space. 3. The instrument of claim 2 wherein said instrument includes a second jaw line cutting member that is constructed for radial motion and is axially stationary. 4. The instrument of claim 1 wherein said first jaw-like cutting member is constructed such that it can be actuated to move transversely into space defined by said second jaw-like member to engage a sample cut by said members prior to said axial motion. 5. The instrument of any one of claims 1, 2, 3 or 4 wherein said cutting member is attached to a tubular member defining said storage space, said tubular member and cutting member including a slot and pin camming arrangement constructed to allow said motions by relative axial movement of ιid tubular member and said cutting member. 6. The instrument of claim 5 wherein said slot is provided on said cutting member and said pin is provided on said tubular member. 7. The instrument of claim 6 wherein said camming arrangement provides, in order, opening motion of said cutting member, closing motion, transverse motion of said cutting member to facilitate engagement with a seτιple cut by said member, axial motion for disposing ε i sample in said storage space, and axial motion for renaming said cutting member to a position in preparation for taking another sample. 8. The instrument of claim 2 including a second jaw like member that is constructed for radial and axial motion. 9. The instrument of claim 8 wherein said first and second jaws are coupled to said instrument at a distal end portion that is rigid relative to a flexible portion proximal thereof. 10. The instrument of claim 9 wherein said rigid distal end portion has an axial length that is about equal to or shorter than the axial length of said jaws. 11. The instrument of claim 10 wherein said rigid distal end portion defines a space that has an axial length that is about equal to the axial length of said jaws, and said jaws are moveable proximally within said distal end portion. 12. The instrument of claim 11 wherein said distal end portion has a length of about 5-7mm. 13. An instrument for obtaining tissue samples from a site deep within the body, the instrument having an elongated proximal portion that is constructed to follow a long, torturous path to said site and having a distal end constructed to remove a tissue sample from the body, including tissue specimens, polyps or the like, wherein said instrument is constructed to take multiple biopsy samples without being withdrawn from the body by including a storage space along the axis of said device suitable for storage of multiple, successively taken samples and a side-facing sampling element constructed such that it can be actuated in a first, rotational motion about the device axis to separate a tissue sample from the body and a second, axial motion for disposing said sample axially to facilitate positioning said sample in said storage space. 14. The instrument of claim 13 wherein said sampling element has an integral, axially adjacent sample-engaging surface for engaging a sample during said axial motion of said element. 15. The instrument of claim 14 wherein said sampling element is a tube-form including a side-facing cutout defining a cutting surface and said sample engaging surface, and said storage space is defined by a portion of said tube-form adjacent said cutout. 16. The instrument of claim 15 wherein said storage space is proximal of said cutting element. 17. The instrument of claim 13 including a retention formation constructed such that said sample can be moved in a first axial direction by said sampling element into contact with said retention formation and said sampling element can be moved in the second axial direction while said sample is retained axially stationary by said retention formation. 18. The instrument of claim 17 wherein said retention formation is a high friction surface. 19. The instrument of claim 18 wherein said sampling element is constructed to prevent abrasion of said sample against said retention formation as said sample is moved axially in said first axial direction. 20. The instrument of claim 19 including an outer sleeve wherein said sampling element is moveable relative to said outer sleeve, and said retention formation is provided on said outer sleeve. 21. The instrument of claim 20 wherein said retention formation is provided on a small portion of the interior surface of said outer sleeve that is about equal to or less than the circumferential width and axial length of the side-facing cutout of said sampling element. 22. The instrument of claim 21 wherein said sampling element includes a scraping surface constructed to move between a tissue sample and said retention formation to facilitate transfer of said sample into said storage space as said sampling element moves in said second axial direction. 23. The instrument of claim 21 wherein said sleeve includes a side-facing opening through which tissue may pass to be engaged by said cutting surface of said sampling member. 24. The instrument of claim 17 wherein said retention formation is formed by sandblasting. 25. The instrument of claim 13 wherein interior sample contacting surfaces of said storage space include a low friction coating that allows easy axial relative displacement of the surfaces and said sample. 26. The instrument of claim 25 wherein said low friction coating is a hydrogel. 27. The instrument of claim 13 further including an axially moveable sample-retaining element constructed to engage and maintain samples in said storage space as said sampling element moves axially into a cutting position.

Inventors: BANIK MICHAEL S, ROBINSON DONALD E, BANIK, MICHAEL, S., ROBINSON, DONALD, E.
Applicants: BOSTON SCIENT CORP, BOSTON SCIENTIFIC CORPORATION
Application year: 1994
Main classification: A61B5
IPC codes: A61B1, A61B10, A61B17